Senior Manager, Quality Systems

About Forge

Our mission at Forge Biologics, is to enable access to life changing gene therapies and help bring them from idea into reality. We partner with innovators in the gene therapy community: scientists, physicians, biotech/pharma companies, and patient groups. We bring expertise in gene therapy manufacturing and therapeutics development to the table, helping to champion teams that are navigating the long road from the lab bench to the bedside. Our goal is simple but vital to patients living with disease, and we take it seriously. With a patient-first approach, we are forging new models for working together to better accelerate these transformative medicines to reach those who need them the most. 

Forge is based in Columbus, Ohio, in a 200,000 square foot facility known affectionately by team members as, the Hearth. The Hearth, is a custom-designed cGMP facility dedicated to AAV manufacturing and hosts scalable, end-to-end manufacturing services.

About The Role

The Senior Manager, Quality Systems is responsible for the management and improvement of the Quality Systems at Forge Biologics. This individual will provide expertise and guidance in interpreting governmental regulations, agency guidelines, and internal policies to ensure compliance. The Senior Manager, Quality Systems will also be responsible for establishing and improving the internal Quality Systems business practices and workflows at Forge. 

What You’ll Do

• Managing quality events and continuous improvement of the Quality Systems including Investigations, Continuous Improvements, CAPAs, Change Controls, and other quality systems implemented at Forge.
• Facilitate the compiling, trending and reporting of key quality metrics for management, and other quality system functions.
• Responsible for implementation and compliance to schedule, conduct, and document Management Review, including preparation of the Management Review Agenda and Minutes.
• Communicate with other technical groups to resolve issues, identify and close gaps, and seek quality compliant outcomes which are efficient and robust.
• Responsible for the authoring or review and approval of controlled documentation including: Standard Operating Procedures (SOPs), Work Instructions, Guidance’s, and other controlled document types.
• Making fast-based, scientifically and/or statistically sound, quality/regulatory compliant decisions that have impact on product release.
• Support hosting client/regulatory inspections, inspection readiness training, and reviewing audit reports and responses, as needed.

What You’ll Bring

• Bachelor’s Degree (B.A. or B.S.) in Biology, Biochemistry, Biomedical Engineering, or related life science field
• Quality Systems experience in an FDA regulated field/industry.
• Experience supporting inspections performed by FDA and/or foreign Regulatory Authorities.
• Strong understanding of Quality Risk Management practices and procedures.
• Thorough knowledge of pharmaceutical cGMP requirements including strong working knowledge of FDA and EU requirements/guidance documents
• Prior management experience
• Intermediate level skill in Microsoft Word, Excel, Outlook, and other office software programs.

Preferred Skills

• Advanced Degree in Biology, Biochemistry, Biomedical Engineering, or related life science field
• Cell & Gene Therapy experience
• Experience with Veeva Vault

Physical Requirements

This position works in both a laboratory environment and typical office environment where the physical work demands will vary depending on the specific tasks and duties required of the job. The employee will be stationary (standing/sitting) for extended periods of time. Employees regularly wear personal protective equipment based on the task being performed. Must be able to work in a confined space, such as a clean room or laboratory environment.

COVID Safety

In our commitment to the safety of our employees and customers, a COVID vaccination is required.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities and activities may change or new ones may be assigned.

 

Forge Biologics is an equal opportunity employer dedicated to building an inclusive and diverse workforce. Forge Biologics, provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation,